Malleo TriStep
Clinical Study Summaries
This document summarizes clinical studies conducted with the Malleo TriStep. The included studies were
identified by a literature search made on PubMed and within the journals Orthopädie-Technik, Medizinisch Orthopädische Technik, Neurologie & Rehabilitation and Journal of Pediatric Orthopaedics.
Table of content:
1 Overview table ....................................................................................................................... p 2
2 Summary of individual study ...................................................................................................p 3-7
Brüggemann et al. 2009 ..................................................................................................... p 4
4 Copyright .............................................................................................................................. p 8
Malleo TriStep – Clinical Study Summaries
Otto Bock Clinical Research & Services
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1 Overview table
The summaries are organized in three levels depending on the detail of information. The overview table (Level 1) lists all the relevant publications dealing with a particular product (topic) as well as researched categories (e.g. gait analysis, clinical effects, satisfaction, etc). By clicking on underlined
categories, a summary of all the literature dealing with that category will open (Level 2).
For those interested to learn more about individual studies, a summary of the study can be obtained by clicking on the relevant reference (Level 3).
Category
Reference
Functions and Activities
Author
Year
Biomechanics –
Static measures
Biomechanics –
Gait analysis
Brüggemann
2009
x
x
1
1
Total number: 1
Malleo TriStep – Clinical Study Summaries
X-Ray
EMG
Participation
Functional tests
x
0
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0
Clinical effects
Satisfaction
x
1
1
0
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2 Summary of individual study
On the following pages you find the summary of study that researched Malleo TriStep. You find
detailed information about the study design, methods applied, results and major findings of the
study. At the end of the summary you also can read the original study authors’ conclusions.
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Reference
Brüggemann, G.-P., Willwacher, S., & Fantini-Pagani, C. H.
Institute of Biomechanics and Orthopaedics, German Sport University Cologne,
Germany.
Evaluation of biomechanical efficacy of a new
orthosis concept for ankle injury therapy
Sports Orthopaedics & Traumatology 2009, 25:223-230.
Products
Malleo TriStep
M1: Basic orthosis + foot shell+ cross strap (Immobilisation and stabilisation)
M2: Basic orthosis + cross strap (Stabilisation)
M3: Basic orthosis (Sensomotor support)
Major Findings
With Malleo TriStep (M1, M2, M3) compared to wearing no orthosis (BA), Aircast
Air-Stirrup, DJO (RE), Tape (TA):
 For all static measures, the Malleo TriStep (especially M1) led to a high
restriction of the max. inversion angle compared to wearing no orthosis:
M1
M2
M3
TA
RE
Unexpected tilting
(30° supination)
-66.7%
-28.2%
-15.4%
-30.7%
-46.2%
“Sleeping simulation”
-90.9%
-72.7%
-50%
-31.8%
-77.3%
 Based on the subjective assessment of the subjects, the M1 supported the
stability and safety of the patient the most.
With Malleo TriStep (M2, M3) compared to wearing no orthosis (BA):
 Improved safety due to significant decrease of max. inversion angle and
plantarflexion with Malleo TriStep (M2 & M3) while walking and running:
Max. inversion angle
Max. plantarflexion
Walking (1.8 m/s):
Decrease up to 47.2%
Decrease up to 29.2%
Running (2.5–3.5 m/s): Decrease up to 51.9%
Decrease up to 30.8%
Max. inversion angle during "sleeping simulation"
Max. inversion angle [°]
25
20
Without orthosis (BA)
Malleo TriStep (M1)
15
Malleo TriStep (M2)
Malleo TriStep (M3)
10
Tape (TA)
Aircast Air-Stirrup (RE)
5
0
Max. inversion angle during “sleeping simulation” (fixed horizontal position, no muscle activity). Max. inversion angle was measured after removing the fixation.
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Population
Subjects:
Mean age:
Mean body mass:
Exclusion criteria:
Study Design
Observational, comparative:
17 patients (10 male, 7 female)
25 ± 2.4 yrs
74 ± 6 kg
Ankle injury within the last 12 months
Measurement 2:
No orthosis (BA)
Tape (TA)
Malleo TriStep, M2
Aircast Air-Stirrup (RE)
Malleo TriStep, M1
Malleo TriStep, M2
Data collection
No orthosis (BA)
Malleo TriStep, M3
Data collection
Measurement 1:
Malleo TriStep, M3
Measurement 1:
With all conditions 3 types of static measures were performed. Test A simulated an
unexpected tilt (30° supination and 30° supination + 10° plantarflexion) of the ankle
by a pneumatic platform. Test B proofed the stabilisation of the ankle while standing
30 seconds on one leg on an instable underground. Test C was a “sleeping simulation” (fixed horizontal position, no muscle activity). Fixation was removed quickly.
Measurement 2:
Gait (1.8 m/s) and running (2.5 & 3.5 m/s) measurements were performed on a
treadmill with three conditions (BA, M2 and M3).
Results
Functions and Activities
Biomechanics –
Static measures
Participation
Biomechanics –
Gait analysis
X-Ray
EMG
Functional tests
Clinical effects
Satisfaction
Category
Outcomes
Results for Malleo TriStep
Biomechanics –
Static measure
Max. inversion
angle
During unexpected tilting (30° supination) all conditions (except M3)
showed significant reductions:
M1 vs. BA
66.7% lower
++
Sig.*
M2 vs. BA M3 vs. BA
28.2%
15.4%
lower
lower
++
+
TA vs. BA
30.7%
lower
++
RE vs. BA
46.2%
lower
++
During unexpected tilting (30° supination + 10° plantarflexion) significant decreases were recorded only for M1:
M1 vs. BA
28° lower
++
Malleo TriStep – Clinical Study Summaries
M2 vs. BA
12° lower
+
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TA vs. BA
12° lower
+
RE vs. BA
18° lower
+
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Functions and Activities
Biomechanics –
Static measures
Category
Participation
Biomechanics –
Gait analysis
X-Ray
Outcomes
EMG
Functional tests
Clinical effects
Satisfaction
Results for Malleo TriStep
Sig.*
For the “sleeping simulation” all inversion angles are significantly reduced compared to BA:
M1 vs. BA
90.9% lower
++
Max. eversion/
inversion
angle
Biomechanics –
Gait analysis
Walking (1.8 m/s)
M2 vs. BA M3 vs. BA
72.7%
50%
lower
lower
++
++
TA vs. BA
31.8%
lower
++
RE vs. BA
77.3%
lower
++
For the max. eversion/inversion angle during standing 30 sec on one
leg, 3 of 5 results were noted as significant:
M1 vs. BA
28.9%
lower
++
M2 vs. BA
13.3%
lower
++
M3 vs. BA
0%
0
TA vs. BA
6.7%
lower
+
RE vs. BA
20%
lower
++
The max. inversion angle while walking was significantly reduced with M2 and M3 condition:
M2 vs. BA
47.2% lower
++
M3 vs. BA
13.3% lower
++
M2 vs. M3
14.3% lower
+
No significant results for the eversion angle were found
0
Plantarflexion while walking was significantly reduced:
M2 vs. BA
29.2% lower
++
M3 vs. BA
22.2% lower
++
M2 vs. M3
8.9% lower
++
Running (2.5 m/s) During running (2.5 m/s), the max. inversion angle was significantly decreased:
M2 vs. BA
49.1% lower
++
M3 vs. BA
34.5% lower
++
M2 vs. M3
22.4% lower
++
No significant results for the eversion angle were found
0
Plantarflexion while running (2.5) was significantly reduced:
M2 vs. BA
27.8% lower
++
M3 vs. BA
20.5% lower
++
M2 vs. M3
9.2% lower
++
Running (3.5 m/s) M2 reduces the max. inversion angle while running (3.5 m/s) by
half:
M2 vs. BA
51.9% lower
++
M3 vs. BA
36.8% lower
++
M2 vs. M3
23.8% lower
++
No significant results for the eversion angle were found
0
During running (3.5 m/s) plantarflexion was significantly reduced
with M2 and M3:
M2 vs. BA
30.8% lower
++
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M3 vs. BA
20% lower
++
M2 vs. M3
13.6% lower
++
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Functions and Activities
Biomechanics –
Static measures
Participation
Biomechanics –
Gait analysis
X-Ray
EMG
Functional tests
Clinical effects
Satisfaction
Category
Outcomes
Results for Malleo TriStep
Sig.*
EMG
Standing 30 sec
on one leg
No significant reduction of activity was found for Mm. peronei
0
Latency time (time
from tilting to
No significant differences.
muscle reaction)
Clinical effects
Visual Analog
Scale (VAS)
(0 “no stability” –
10 “best possible
stability”)
0
According to the VAS during standing 30 sec on one leg, the
M1 (8.6) was found to support the stability and safety of the
patient the most. Afterwards the M2 (6.5), RE (5.7) and TA
(4.9) follow.
n.a.
* no difference (0), positive trend (+), negative trend (−), significant (++/−−), not applicable (n.a.)
Author’s Conclusion
“In summary, a significant decrease in the KAM could be observed in subjects with
knee varus alignment while using an AFO in different adjustments (4° valgus, neutral, and 4° varus). The orthosis was effective in changing the knee joint alignment
and the knee joint lever arm in the frontal plane. Long-term effects on the KAM,
symptoms, joint function, and compliance in patients with medial knee OA should
be investigated in future studies. The use of AFOs designed to change the tibia
position and thereby the knee joint alignment in the frontal plane could represent an
alternative for conservative treatment of knee OA.” (Fantini-Pagani et al. 2013)
 Back to overview table
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Copyright:
© 2014, Otto Bock HealthCare Products GmbH (“Otto Bock”). All Rights Reserved. This
document contains copyrighted material. Wherever possible we give full recognition to the
authors. We believe this constitutes a ‘fair use‘ of any such copyrighted material according to Title
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property of their respective owners. The information presented here is in summary form only and
intended to provide broad knowledge of products offered. You should consult your physician
before purchasing any product(s). Otto Bock disclaims any liability related from medical decisions
made based on this document.
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